Subcutaneously injected insulin has been used to treat diabetes since the 1920s. Despite studies showing long-term benefit of tight glycemic control with aggres-sive insulin therapy, it has been slow to gain acceptance. The present study investigates the clinical utility of pre-meal intrapulmonary delivery of insulin in subjects with Type I Diabetes using a novel dry powder insulin formulation and aerosol delivery device and whether glycemic control can be achieved as effectively as with a conventional subcutaneous insulin regimen.